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The prospective randomized control study to evaluating partial injection underwater endoscopic mucosal resection for superficial duodenal epithelial tumor

The prospective randomized control study to evaluating partial injection underwater endoscopic mucosal resection for superficial duodenal epithelial tumor - PI-UEMR study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000041860
Enrollment
130
Registered
2020-09-30
Start date
2020-09-28
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Superficial non-ampullary duodenal epithelial tumor

Interventions

Partial injection underwater endoscopic mucosal resection (PI-UEMR) Sodium hyaluronate is used for submucosal injection agent. Underwater endoscopic mucosal resection (UEMR)

Sponsors

Keio University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients over 20 years of age scheduled for endoscopic treatment of lesions diagnosed as non-ampullary duodenal adenoma of 13-20 mm 2) Tumors without stalk 3) Patients who agreed to participate in the study

Exclusion criteria

Exclusion criteria: 1) Cases in which snaring is considered difficult due to poor maneuverability 2) Cases in which suspected submucosal invasive cancer 3) Cases of chronic kidney disease needs dialysis 4) Cases of uncompensated liver cirrhosis 5) Cases of hematologic disease with coagulation dysfunction 6) Cases where antithrombotic management is not possible according to the guidelines of the Japan Gastroenterological Endoscopy Society (Case of a low dose aspirin is enable to treatment without drug withdrawal. 7) Cases of other critical organ failure 8) Cases of multiple duodenal tumors associated with hereditary bowel diseases (i. e; familial colorectal polyposis) 9) Other casess deemed ineligible at a preoperative conference

Design outcomes

Primary

MeasureTime frame
En bloc resection rate with pathologically confirmed negative margins without conversion to ESD (R0 resection rate)

Secondary

MeasureTime frame
Amount of submucosal injection agents, procedure time, en bloc resection rate, macroscopic and pathological margin, intra- and post operation complication, conversion rate to ESD

Countries

Japan

Contacts

Public ContactYusaku Takatori

Keio University School of Medicine Cancer Center

y_takatori@keio.jp03-3353-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026